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NCT Number: NCT05365815

Melanated Group Midwifery Care (MGMC)

This study is being conducted to determine if a multi-level intervention for delivering maternity care can improve patient trust and engagement among Black birthing people.

Recruiting

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Key information

Age range

15 year–49 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

About this study

Low-risk pregnant participants will be randomized into Melanated Group Midwifery Care or usual individualized obstetric care. In Melanated Group Midwifery Care (MGMC), Black women will receive prenatal care from a Black midwife in groups with the same 8-10 other Black women throughout pregnancy. In pregnancy and into the first year postpartum, MGMC patients will stay connected to the health system through a proactive care coordinator, who is a Black licensed nurse. For the first year after giving birth, patients in MGMC will also be supported by a trained postpartum doula.

All participants (intervention and usual care groups) will complete study measures that include validated surveys on patient trust, respect and engagement at 6 time points:

  • 3 time points in pregnancy [baseline (<20 weeks), 26-28 weeks, and 35- 37 weeks] and
  • 3 in the postpartum at 2-, 6-, and 12-months
  • Additional qualitative interviews will be done to track the care received by medically and socially complex patients, including all who experience a severe maternal morbidity.

The investigators will also document how MGMC gets embedded in practice through a qualitative process evaluation.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

for patients:

  • pregnant women who self-identify as Black on a standard prenatal intake form
  • less than 20 weeks pregnant
  • 15 years old or older
  • present to the general obstetrics group at the University of Chicago Medical Center for their new prenatal visit
  • speak and understand English

Inclusion criteria

for providers:

  • All black midwives, care coordinators, and community postpartum doulas at the University of Chicago are eligible to participate.

Exclusion criteria

for patients:

  • having a condition for which they present to a higher level of obstetrics care (e.g., maternal fetal medicine) for their new prenatal visit
  • having a cognitive issue that impairs their ability to give informed consent.

Treatment and study plan

Melanated Group Midwifery Care

Behavioral

Racially concordant maternity care Group prenatal care Racially concordant nursing care coordination Postpartum doula support

Primary outcomes

  1. Patient Engagement-Prenatal Adequacy

    Time frame: Birth (T3)

    Appropriate number (yes/no) and timing of prenatal visits (yes/no) documented in electronic medical records

  2. Patient Engagement-Prenatal Adherence

    Time frame: Birth (T3)

    Five tests completed during prenatal period (yes/no), documented in electronic medical record

  3. Patient Engagement-Postnatal adequacy

    Time frame: 1 year postpartum (T6)

    Appropriate number (yes/no) and timing of postnatal visits (yes/no) documented in electronic medical record

Secondary outcomes

  1. Patient activation

    Time frame: Change from baseline through 12 months postpartum (T6)

    Patient Activation Measure (PAM), 13-item scale, range 0-100, Likert disagree strongly to agree strongly and not applicable. Assesses degree to which individuals take an active role in managing health and health care. Higher scores are more likely to understand that their active involvement is critical to their state of health and considered more ''in charge.'' The PAM has strong psychometric properties and is predictive of a wide range of health-related behaviors. Hibbard et al. report that a 4-point difference in PAM scores can be viewed as clinically significant.

  2. Patient Autonomy

    Time frame: Change from baseline through 12 months postpartum (T6)

    Mothers Autonomy in Decision-Making Scale. 7 item scale, Likert completely disagree to completely agree. Assesses the degree to which patients were given decision-making for healthcare decisions, and if patients felt respected by providers. Higher scores indicate that providers supported patient autonomy and patient decision-making.

  3. Provider Trust

    Time frame: Change from baseline through 12 months postpartum (T6)

    Trust in Physician Scale, 11 items, range 11-55, Likert 1-5; α =0.85-0.90.

  4. Patient Satisfaction

    Time frame: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)

    22 items; 5-point Likert (excellent to poor); α =0.95. Excellent reliability and construct validity, taps six established dimensions of satisfaction (art of care, technical quality, access, physical environment, availability, and efficacy)

  5. Mental Well Being

    Time frame: Change from baseline through 12 months postpartum (T6)

    Computerized Adaptive Testing - Mental Health: assessing depression, anxiety, suicidality, substance use disorder, and social determinants of health.

  6. Respectful Care

    Time frame: Change from late pregnancy (35-37 gestational weeks) (T3) and 2 months postpartum (T4)

    Mothers on Respect index (MORi) quantifies women's sense of disrespect and dismissal when engaging in conversation with providers, 14 items, Likert, ranging from 1-strongly disagree to 6-strongly agree. α =0.94

Other outcomes

  1. Medical Referrals

    Time frame: 12 months postpartum (T6)

    Referrals to higher acuity medical or obstetric care

  2. Social Referrals

    Time frame: 12 months postpartum (T^)

    Referrals to higher acuity mental health or social services

Study contacts

Contact information is provided by the study sponsor or research team.

Kylea L Liese, PhD

CONTACT

[email protected]

3129961867

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Patient-Centered Outcomes Research Institute
  • University of Chicago

Registry information

Official study title

Black Midwives for Black Women: Maternity Care to Improve Trust and Attenuate Structural Racism

Acronym: MGMC

Important dates

Study start
2022
Primary completion
2026
Study completion
2027
First posted
May 9, 2022
Registry last updated
Jul 3, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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